Vedolizumab improves clinical outcomes, induces mucosal healing in UC, chronic pouchitis
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Key takeaways:
- Patients on vedolizumab had greater reduction in mean ulcer count at weeks 14 and 34 vs. those on placebo.
- More vedolizumab-treated patients also achieved mucosal healing at week 14.
Vedolizumab not only induced endoscopic improvements in patients with chronic pouchitis, but also appeared to improve clinical outcomes at week 34, especially in those who achieved mucosal healing at week 14, research showed.
“The primary results from EARNEST showed that treatment with vedolizumab demonstrated clinically meaningful and statistically significant superiority relative to placebo for the primary endpoint of clinical remission at week 14,” Vipul Jairath, MBChB DPhil, professor of medicine at the Schulich School of Medicine and Dentistry at Western University, and colleagues wrote in Clinical Gastroenterology and Hepatology. “Treatments now aim to achieve mucosal healing using endoscopic and histologic criteria in distinction to relief from symptoms.
“However, it is unclear whether achievement of mucosal healing in patients with pouchitis is associated with improvement in clinical outcomes.”
In an additional analysis of the randomized, double-blind, placebo-controlled EARNEST study, the researchers evaluated whether vedolizumab was effective in inducing endoscopic improvement and mucosal healing in patients with chronic pouchitis.
They included 102 adult patients with chronic pouchitis following proctocolectomy and ileal pouch anal anastomosis (IPAA) for ulcerative colitis, who were randomly assigned to treatment with vedolizumab or placebo (n = 51 each).
Patients underwent pouchoscopy at baseline and weeks 14 and 34, with findings scored using the adapted Simple Endoscopic Score for Crohn’s Disease (SES-CD) and Pouch Disease Activity Index (PDAI), as well as symptom assessment. In addition, patients provided quality of life assessments at those time points via the Inflammatory Bowel Disease Questionnaire (IBDQ).
At baseline, the researchers reported a mean SES-CD of 5.8 in the vedolizumab group and 5.5 in the placebo group, with a PDAI score of 10.5 in both groups.
From baseline to week 14, the mean number of ulcers decreased from 15.1 to 5 in the vedolizumab group vs. 11.8 to 13.4 in the placebo group (difference = –8.4; 95% CI, –14.3 to –2.6), with further reductions to 2.7 vs. 9.7, respectively, at week 34 (difference = –7; 95% CI, –12 to –2).
In addition, more patients in the treatment group achieved a reduction in ulcerated pouch surface area at week 14 (52.4% vs. 20%) and week 34 (52.1% vs. 12.9%), as well as absence of ulcers (23.8% vs. 7.5% and 34.4% vs. 15.6%) and SES-CD remission (23.8% vs. 7.5% and 34.4% vs. 15.6%).
Jairath and colleagues also reported a greater proportion of vedolizumab-treated patients achieved mucosal healing at week 14 (16.7% vs. 2.5%), which appeared to be associated with improvements in PDAI and IBDQ remission at both timepoints.
“Vedolizumab treatment in the EARNEST study induced and maintained endoscopic improvements in patients with chronic pouchitis following proctocolectomy and IPAA for UC,” Jairath and colleagues wrote. “These improvements were associated with improved clinical outcomes vs. placebo at week 34, particularly in patients with mucosal healing at week 14. The evaluation of endoscopic endpoints should be included in future trials in pouchitis.”
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